Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia?

NCT01312272 | Completed Results

• 1 other identifier: PCC 2011-020223
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with schizophrenia have been found to have deficits in social cognition, which is defined as the functions that are engaged during social interactions. Social cognition has been found to be critical in predicting multiple aspects of community functioning. There are no currently available medications that have been consistently found to improve social cognition in individuals with schizophrenia. Oxytocin functions as a neurotransmitter that is thought to be involved in multiple aspects of social behavior and related emotions. In this study, we test the hypothesis that acute administration of intranasal oxytocin will improve social cognition in individuals with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; Social Intelligence; Perception, Social; Oxytocin

Outcome Measures

Primary Outcomes (1)

• Social Cognition Composite Measure

  Our primary outcome measure will be a composite score created by calculating the mean of the four main social cognition measures assessed in this study (two "high-level" measures and two "low-level" measures). Because these measures are not on the same scale, we will first z-score (center and scale) each of the four measures at each time point using the baseline mean and standard deviation of the whole sample and then calculate the mean of the z-scores to create the composite social cognition score.

  Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

Secondary Outcomes (5)

• Theory of Mind Assessment (High Level Social Cognition)

  Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

• Empathy

  Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

• Social Perception Assessment (Low Level Social Cognition)

  Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

• Facial Affect Recognition (Low Level Social Cognition)

  Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

• Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score

  Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

Study Arms (2)

Inactive nasal spray

PLACEBO COMPARATOR

A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.

Drug: Inactive placebo nasal spray

Intranasal Oxytocin

EXPERIMENTAL

Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.

Drug: Oxytocin

Interventions

Oxytocin DRUG

Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time

Intranasal Oxytocin

Inactive placebo nasal spray DRUG

A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.

Inactive nasal spray

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Veteran being treated in the Veterans Administration Healthcare System
• Meet DSM-IV-TR criteria for Schizophrenia
• At least 6 months since any hospitalization or substantial increase in level of care for an acute exacerbation of psychotic symptoms
• At least 1 month since meeting the criteria for having a major depressive episode
• At least 6 months since any behaviors suggesting any potential danger to self or others
• Adherence to the regular administration of an antipsychotic medication (e.g., risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, paliperidone, iloperidone, asenapine, fluphenazine, haloperidol, loxapine, molindone, perphenazine, thiothixene, chlorpromazine, clozapine)
• Dose of antipsychotic medication not varying by more than 25% over the 3 months prior to study participation
• No acute medical problems
• Chronic medical conditions (e.g., hypertension, diabetes, dyslipidemia) consistently treated and stable for at least 3 months prior to study participation
• Ability to provide signed informed consent and to cooperate with study procedures

You may not qualify if:

• Documented history of mental retardation or severe learning disability
• History of treatment with electroconvulsive therapy within 6 months prior to study participation
• History of neurological or neuropsychiatric condition (e.g., stroke, severe traumatic brain injury, epilepsy, etc.)
• Documented history of persistent substance abuse or dependence within 6 months prior to study participation
• History of hyponatremia within the past 6 months
• Allergic rhinitis or other inflammation of the nasal mucosa

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead

Study Sites (1)

West Los Angeles VA Healthcare Center

Los Angeles, California, 90073, United States

Location

Related Publications (10)

• Bartz JA, Zaki J, Bolger N, Hollander E, Ludwig NN, Kolevzon A, Ochsner KN. Oxytocin selectively improves empathic accuracy. Psychol Sci. 2010 Oct;21(10):1426-8. doi: 10.1177/0956797610383439. Epub 2010 Sep 20. No abstract available.

  PMID: 20855907 BACKGROUND

• Domes G, Heinrichs M, Michel A, Berger C, Herpertz SC. Oxytocin improves "mind-reading" in humans. Biol Psychiatry. 2007 Mar 15;61(6):731-3. doi: 10.1016/j.biopsych.2006.07.015. Epub 2006 Nov 29.

  PMID: 17137561 BACKGROUND

• Feifel D, Macdonald K, Nguyen A, Cobb P, Warlan H, Galangue B, Minassian A, Becker O, Cooper J, Perry W, Lefebvre M, Gonzales J, Hadley A. Adjunctive intranasal oxytocin reduces symptoms in schizophrenia patients. Biol Psychiatry. 2010 Oct 1;68(7):678-80. doi: 10.1016/j.biopsych.2010.04.039. Epub 2010 Jul 7.

  PMID: 20615494 BACKGROUND

• Goldman M, Marlow-O'Connor M, Torres I, Carter CS. Diminished plasma oxytocin in schizophrenic patients with neuroendocrine dysfunction and emotional deficits. Schizophr Res. 2008 Jan;98(1-3):247-55. doi: 10.1016/j.schres.2007.09.019. Epub 2007 Oct 24.

  PMID: 17961988 BACKGROUND

• Guastella AJ, Mitchell PB, Dadds MR. Oxytocin increases gaze to the eye region of human faces. Biol Psychiatry. 2008 Jan 1;63(1):3-5. doi: 10.1016/j.biopsych.2007.06.026. Epub 2007 Sep 21.

  PMID: 17888410 BACKGROUND

• Keri S, Kiss I, Kelemen O. Sharing secrets: oxytocin and trust in schizophrenia. Soc Neurosci. 2009;4(4):287-93. doi: 10.1080/17470910802319710. Epub 2008 Aug 1.

  PMID: 18671168 BACKGROUND

• Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.

  PMID: 15931222 BACKGROUND

• Shamay-Tsoory SG, Fischer M, Dvash J, Harari H, Perach-Bloom N, Levkovitz Y. Intranasal administration of oxytocin increases envy and schadenfreude (gloating). Biol Psychiatry. 2009 Nov 1;66(9):864-70. doi: 10.1016/j.biopsych.2009.06.009. Epub 2009 Jul 29.

  PMID: 19640508 BACKGROUND

• Webber MA, Marder SR. Better pharmacotherapy for schizophrenia: what does the future hold? Curr Psychiatry Rep. 2008 Aug;10(4):352-8. doi: 10.1007/s11920-008-0056-8.

  PMID: 18627675 BACKGROUND

• Davis MC, Lee J, Horan WP, Clarke AD, McGee MR, Green MF, Marder SR. Effects of single dose intranasal oxytocin on social cognition in schizophrenia. Schizophr Res. 2013 Jul;147(2-3):393-7. doi: 10.1016/j.schres.2013.04.023. Epub 2013 May 12.

  PMID: 23676253 RESULT

Related Links

• Link to PubMed journal article citation for peer-reviewed publication describing study

MeSH Terms

Conditions

Schizophrenia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Michael C. Davis
• Organization: VISN 22 Mental Illness Research, Education, and Clinical Center

mcdavis@mednet.ucla.edu

3104783711

Study Officials

• Stephen R Marder, M.D.

  VA Greater Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow / Physician

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 10, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 2, 2014
• Results First Posted: May 2, 2014

Record last verified: 2014-03

Locations

US (1)